A randomized, prospective, double-blind study with placebo to evaluate the efficacy of treatment of patients with angina resistant to pharmacological treatment and induced myocardial ischemia without possibility of effective revascularization, using isolated from bone marrow, autological CD133+ cells administered directly into the muscle of left ventricle. REGENT-VSEL Study. - REGENT VSEL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005435-98-PL

Enrollment

Unknown

Registered

2012-02-24

Start date

2012-06-21

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable angina pectoris CCS II-IV MedDRA version: 14.1 Level: LLT Classification code 10049194 Term: Stable angina pectoris System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: autological CD133+ isolated from bone marrow Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placeb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Stable angina CCS II-IV despite maximum pharmacotherapy for at least 2 weeks since last medications change 2. Presence of = 1 miocardium segment with ischemia features in Tc-99m SPECT 3. Patients disqualified from revascularization procedures by heart-team 4. Patient age > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. acute coronary syndrome in less than 6 months prior to enrollment 2. heart failure NYHA III-IV 3. LVEF<35% 4. presence of intracardiac thrombus (echocardiography confirmed), massive calcification of the aortic valve and left ventricular aneurysm 5. status after cardioverter defibrillator or cardiac stimulator implantation 6. allergy to contrast agents 7. malignancy in medical interview 8. HIV, HBV, HCV infection 9. status associated with life expectancy less than 6 months 10. bleeding diathesis 11. renal insufficiency (GFR < 30 mL/min/1.73m2) 12. pregnancy, lactation, or lack of effective contraception in women of childbearing age

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Assessment of influence of direct administration of isolated from bone marrow, autological CD133+ cells on improvement of myocardial perfusion and function and decrease of occurrence of symptomatic angina of patients with angina resistant to pharmacological treatment without possibility of effective revascularization 2. Assessment of therapy safety ;Secondary Objective: ;Primary end point(s): Myocardial perfusion change assessed by perfusion scintigraphy (99mTc SPECT) 4 months after application of cell therapy ;Timepoint(s) of evaluation of this end point: 4 months after application of cell therapy	—

Measure

Time frame

Main Objective: 1. Assessment of influence of direct administration of isolated from bone marrow, autological CD133+ cells on improvement of myocardial perfusion and function and decrease of occurrence of symptomatic angina of patients with angina resistant to pharmacological treatment without possibility of effective revascularization 2. Assessment of therapy safety ;Secondary Objective: ;Primary end point(s): Myocardial perfusion change assessed by perfusion scintigraphy (99mTc SPECT) 4 months after application of cell therapy ;Timepoint(s) of evaluation of this end point: 4 months after application of cell therapy

—

Secondary

Measure	Time frame
Secondary end point(s): 1. global and segmental contractility change and myocardial perfusion change assessed by magnetic resonance imaging with adenosine administration, and echocardiography with contrast 2. exercise tolerance assessed in a treadmill test (TET, ESTD, TTLA) 3. occurrence of symptomatic angina (CCS, nitrates usage) 4. quality of life assessed by standard questionnaires (SF37, Seattle Angina) ;Timepoint(s) of evaluation of this end point: 1. 4 months after application of cell therapy 2. 4 and 6 months after application of cell therapy 3. 1, 4, 6 and 12 months after application of cell therapy 4. 1, 4, 6 and 12 months after application of cell therapy	—

Measure

Time frame

Secondary end point(s): 1. global and segmental contractility change and myocardial perfusion change assessed by magnetic resonance imaging with adenosine administration, and echocardiography with contrast 2. exercise tolerance assessed in a treadmill test (TET, ESTD, TTLA) 3. occurrence of symptomatic angina (CCS, nitrates usage) 4. quality of life assessed by standard questionnaires (SF37, Seattle Angina) ;Timepoint(s) of evaluation of this end point: 1. 4 months after application of cell therapy 2. 4 and 6 months after application of cell therapy 3. 1, 4, 6 and 12 months after application of cell therapy 4. 1, 4, 6 and 12 months after application of cell therapy

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Countries

Poland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026